National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)

August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

May 14, 2013 - See Notice NOT-NS-13-029. Notice of Participation of Additional NIH Institutes and Centers.

The mission of the CounterACT U01 program is to develop new
and improved therapeutics for chemical threats. Chemical threats are toxic
chemicals that could be used in a terrorist attack or accidentally released
from industrial production, storage or shipping. They include traditional chemical
warfare agents, toxic industrial chemicals, and pesticides. Applicants are
encouraged to contact the Program Officials listed in this FOA to determine
if their proposed threat agent(s) or countermeasure(s) is of high program
priority for one of the participating Institutes. The scope of the research
to be supported includes target and candidate identification and characterization,
through candidate optimization and demonstration of in vivo efficacy, through
Investigational New Drug (IND) submission when appropriate. Each project must
include milestones that create discrete go or no-go decision points in a
progressive translational study plan.

Key Dates

Posted Date

April 25, 2013

Open Date (Earliest Submission Date)

August 16, 2013

Letter of Intent Due Date(s)

August 16, 2013; August 16, 2014; August 16, 2015

Application Due Date(s)

September 16, 2013; September 16, 2014; September 16, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January 2014; January 2015; January 2016

Advisory Council Review

May 2014; May 2015; May 2016

Earliest Start Date

July 1, 2014; July 1, 2015; July 1, 2016.

Expiration Date

September 17, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The overall goal of the NIH CounterACT program is to reduce
mortality and morbidity during and after emergency events involving the release
of chemical threat agents. Chemical threat agents are toxic chemicals that
could cause mass casualties after being released by a deliberate terrorist
attack, or by industrial accident or natural disaster. The purpose of this U01 funding
opportunity is to foster and support the development of Food and Drug
Administration (FDA)-approved therapeutics that can be used effectively to
treat individuals during a chemical emergency event.

Background

The NIH has developed a comprehensive CounterACT Research
Program that includes a research network of Research Centers of Excellence,
individual research projects, contracts and Interagency Agreements with the Department
of Defense. The network conducts basic, translational, and clinical research
aimed at the discovery and/or identification of better medical countermeasures
against chemical threat agents, and it supports their development towards FDA
approval. The CounterACT U01 program described in this FOA is designed to
support investigator-initiated individual research projects. To ensure that
the research is translational in nature, CounterACT research projects are milestone-driven
U01 cooperative agreements with substantial scientific and programmatic
involvement by NIH staff.

CounterACT cooperative agreement U01 Program Directors/Principal
Investigators (PDs/PIs) will become members of the CounterACT Research Network,
and will be able to utilize its resources such as the CounterACT Preclinical
Development Facility (CPDF) (see http://www.ninds.nih.gov/research/counterterrorism/
cpdf.pdf). They will be expected to participate in annual meetings of the
national CounterACT Research Network to share information and ideas. The CounterACT
program at NIH is part of the larger biodefense program overseen by the National
Institute of Allergy and Infectious Diseases (NIAID) that includes biological
and radiation/nuclear threats (http://www.niaid.nih.gov/topics/biodefenserelated/Pages/default.aspx).
Also see www.medicalcountermeasures.gov which facilitates communication between federal government agencies and public
stakeholders to enhance the Nation's public health emergency preparedness.

Chemical Threats

The civilian chemical threat spectrum includes chemical
warfare agents, toxic industrial chemicals, pesticides, toxins and other
chemicals. Applicants are strongly urged to contact the Program Officials
listed in this FOA to determine if their proposed threat agent(s) or countermeasure(s)
is of high programmatic priority for funding under the CounterACT U01 program.
It is critical to contact NIH staff early, before time and effort are invested
in developing an application to support research on a chemical or group of
chemicals that is not a priority to the NIH, or does not complement the
existing NIH CounterACT research portfolio (see http://www.ninds.nih.gov/research/counterterrorism/counterACT_researchers_projects.htm).

Special Biosafety Certification

Many of the chemical threat agents of interest are extremely
hazardous to humans. This FOA will only consider supporting studies deemed safe
for research personnel and the environment by appropriate official
institutional biosafety review. Special biosafety certifications may be
required to conduct research with some chemical threat agents, e.g. nerve
agents. Therefore, when applicable, applicants are encouraged to
collaborate with laboratories that are certified to work with restricted
chemical agents, such as the US Army’s Medical Research Institute of Chemical
Defense (http://chemdef.apgea.army.mil/). Applicants
are encouraged to contact the NINDS Scientific/Research
Contact listed in this FOA for further information on working with
restricted chemical agents.

Broad Spectrum Therapeutics

Antidotes that are specific to a chemical will be
considered, however, applicants should also consider research on acute effects
and pathologies that are common to several chemical threat agents, so that the
therapeutics being developed will have a broader spectrum of activity against
more than one chemical.

Scientific Scope

This FOA will only support translational research.
Translational research is the process of applying ideas, insights, and
discoveries generated through basic scientific inquiry to the treatment or
prevention of human disease. The categories of research supported under this
program include but are not limited to:

Mechanistic research to identify targets for therapeutic development.

Creation and development of screening assays for therapy
development. The assay must also be validated and the method of validation
well-justified, e.g. appropriate pharmacology, robustness,relevant pathology, etc.

Creation and validation of animal models of chemical effects on
humans. The goal of this research is to develop models of lethality and serious
morbidity that can be extrapolated to humans, and the intended use of the model
must be for therapeutic development.

Identification of candidate therapeutics using primary or
secondary screening efforts.

Development of preliminary proof-of-principle data on the
efficacy of candidate therapeutics.

Advanced efficacy studies with appropriate animal models

Preliminary and advanced preclinical research including safety
and pharmacokinetic studies with candidate therapeutics

therapeutic intervention are not a description of specific
aims and experiments, but rather are discreet goals that create go or no-go decision
points in the project that include quantitative success criteria. For examples of
acceptable milestones, see http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm . Annual milestones may be modified in negotiations with NIH program
officials before an initial award is made, and during the review of annual
non-competitive renewal applications. Unmet milestones will have a negative
impact on the review and approval of these annual renewal applications.

If a specific new therapy has not yet been identified, the
proposed translational research should demonstrate a clear path towards
identification of a lead compound by the end of the project period. Lead
compounds are biologically active compounds or hits where affinity, potency,
and selectivity have been established. If the project goals are related to
model development, then the model(s) should be fully developed and validated by
the end of the project period. Validation includes a demonstration of the
model’s predictive value for screening compounds for the desired therapeutic
effect.

Research Topic Examples

Specific examples of relevant research topics include but
are not limited to those listed below:

Therapies based on acute toxicity of the chemical threat agent,
e.g. development of new and/or improved anticonvulsants, new
approaches to counteract pulmonary edema, relevant anti-inflammatory drugs,
surfactants, antioxidants, the development of better skin and eye protectants.

Natural history animal models of the acute toxicity of chemical
threat agents. These studies could include characterization of long-term
effects after sub-lethal acute exposures to chemical threats agents, e.g. neuroprotectants
for neurodegeneration and other neurological sequelae, drugs to prevent
long-term fibrosis in the lung, etc.

Studies on the special vulnerabilities of pediatric populations
and pregnant women as they relate to the development of therapeutics, e.g.
acute effects on the developing brain that have long-term effects, the need for
therapeutics dosing schedules and routes of administration that are more
suitable for children and pregnant women.

Research on the molecular mechanisms of toxicity for the purpose
of identifying novel targets, e.g. the mechanisms of nerve agent-induced
seizures with respect to temporal and regional changes, roles of cardiac versus
neuronal mitochondria in cyanide toxicity, cellular and molecular basis for
agent induced pulmonary edema.

Alternate routes of administration for new or approved therapies
that would be safe, effective, and easy to administer during a mass casualty
scenario, e.g. intramuscular route.

Special Considerations

Because of the urgency in need, and the lengthy time and
expense for bringing a new compound to regulatory approval, applicants are
encouraged to consider drugs that are already approved by the FDA for other indications.
Some of these drugs have been shown to be effective in treating victims of
chemical exposures, and in some cases, the length of time to regulatory
approval for a new indication may be shorter than for a novel compound.
Applicants are urged to contact the Scientific Contacts listed in this FOA for
more information related to the FDA, including FDA contacts.

For applications beyond the basic research stage, it may be
advantageous to establish a collaboration with an industry partner who may be
able to assist in developing a plan to advance the studies towards FDA approval
and commercialization.

This FOA will only support translational research that is
clearly relevant to the development of therapeutics that will enhance our
medical response capabilities during an emergency. New medical countermeasures
that have no practical use during a mass casualty situation are not appropriate
to this FOA. Drugs only effective if given prior to chemical insult (prophylaxis)
or those that must be given within a very short period (1-15 minutes) after the
insult will be of low priority. Since many chemical threats have rapid modes of
action, the drug should act rapidly to counter these effects. The ultimate
intended use of a drug should be discussed within the application, including
timing and route of administration that are consistent with its effective use
in an emergency civilian setting. For example, drugs that are only effective
when administered intravenously would be of low priority since their use would
be impractical in a mass casualty situation. Model development, screening activity
and efficacy studies should be designed and justified with these ultimate
requirements under consideration.

Special consideration will be given to research relevant to
people who are particularly vulnerable, including the young, the elderly, and
individuals with pre-existing medical conditions. Pregnant women, infants and
children are particularly vulnerable to the effects of chemical agents. Animal
models and studies that address these vulnerabilities will be of high priority.

To assess the predictive value of preclinical research for
therapeutic development, sufficient information must be presented about the
proposed study design, execution, and interpretation of the supporting data or
results in the grant application. Critical elements of a well-designed study
include adequate scientific rigor, control of bias, reproducibility,
dose-response, confirmation of mechanism, and transparency of reporting. As
such, the NIH urges applicants to this FOA to consider and directly address
these elements in their application(s).

Renewal Applications

A renewal application must be consistent with the scope of
research of this FOA and clearly build upon the scientific advances made during
the previous award.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The participating Institutes intend to commit on average $3
million per year in Fiscal Years 2014, 2015, and 2016 to fund approximately 10-20
awards.

Because the nature and scope of the proposed research will
vary from application to application, it is anticipated that the size and
duration of each award will also vary.

Award Budget

Application budgets are not limited, but need to reflect the
actual needs of the proposed project. For most studies within the scope of
this FOA, the expected direct cost for individual awards is $300,000-$500,000
per year for a total of $1.5-2.5 million over a maximum five-year project
period.

Award Project Period

The total project period may not exceed 5 years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, required and optional. Please note that some components
marked optional in the application package are required for submission of
applications for this FOA. Follow all instructions in the SF424 (R&R)
Application Guide to ensure you complete all appropriate “optional” components.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed. with the following additional instructions:

Many of the chemical threat agents of interest are extremely
hazardous to humans. Applicants must include a letter from appropriate
institutional biosafety officials indicating that studies are deemed safe for
research personnel and the environment. This must also be addressed in the
application, including a description of adequate protection and safeguards if
required. Special biosafety certifications may be required to conduct
research with some restricted chemical threat agents, e.g. nerve agents.
Therefore, when applicable, applicants must include a letter from appropriate
Department of Defense (DoD) officials for use of restricted agents under their
authority.

A formal letter of collaboration (and estimated budget, if
applicable) should be provided with the application for all proposed
collaborative arrangements, especially those utilizing restricted chemicals.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Letter

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

The application should describe in detail how the proposed research
will lead to the development of a validated model and/or lead compound, and it
should present milestones related to achieving that goal. Milestones for each
year of the project should be listed in the Research Strategy section of the
application.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date. If a Changed/Corrected application is submitted after the deadline,
the application will be considered late.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management. Additional information may be
found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Applications that are
incomplete will not be reviewed.

In order to expedite review, applicants are requested to
notify the NINDS Referral Office by email at nindsreview.nih.gov@mail.nih.gov when the application has been submitted. Please include the FOA number and title,
PD/PI name, and title of the application.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before
submitting the application and follow the Policy on the Acceptance for Review
of Unsolicited Applications that Request $500,000 or More in Direct Costs as
described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, the NIH is encouraging
applications for translational research that may involve standard methodologies
applied toward novel therapeutic approaches. It is recognized that due to the
nature of translational research, some studies such as preclinical safety may
include standard routine tests that would not necessarily be innovative.

Additionally, reviewers should consider whether the proposed
research significantly advances scientific knowledge that may predictably reduce
mortality and morbidity during and after emergency events involving the release
of chemical threat agents.

Lastly, reviewers should consider whether the proposed
project milestones are adequate for advancing the goals of the project in a
timely manner, and if the milestones are described with quantitative success
criteria that facilitate go or no-go decisions.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the project address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative interventions
that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For additional
information on review of the Human Subjects section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Are special biosafety precautions for working with
highly toxic chemicals adequate? Have all proposed studies been deemed
safe for research personnel and the environment by appropriate official
institutional biosafety review? If working with restricted chemical
warfare agents, are appropriate approvals and/or collaboration(s) in place?

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned to the NINDS. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this
program will be the cooperative agreement, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the NIH purpose
is to support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.

The PD(s)/PI(s) will have the primary responsibility for:

Defining objectives and approaches, and to plan, conduct,
analyze, and publish results, interpretations, and conclusions of their
studies.

Awardees are responsible for developing and proposing
specific milestones toward the development of therapeutics that will be
achieved during the project period.

Awardees agree to participate in the overall NIH research
effort to develop medical countermeasures against chemical threats. This
participation includes collaboration and consultation with other CounterACT
research awardees at annual meetings of the CounterACT Research Network. Collaboration
may include sharing of information and research materials.

The awardee is solely responsible for the timely acquisition
of all appropriate proprietary rights, including intellectual property rights,
and all materials needed for the applicant to perform the project.

Intellectual Property: Awardees will retain custody of and
have primary rights to the data developed under these awards, subject to
Government rights of access consistent with current HHS, PHS, and NIH
policies.

Before, during, and subsequent to the award, the U.S.
Government is not required to obtain for the awardee any proprietary rights,
including intellectual property rights, or any materials needed by the awardee
to perform the project.

NIH staff have substantial programmatic involvement that
is above and beyond the normal stewardship role in awards, as described below:

An NIH Project Scientist will have substantial programmatic
involvement that is above and beyond the normal stewardship role in awards, as
described below:

Each project will have the support of one or more Project
Scientist(s) from NIH Program staff who are assigned an administrative role for
the project and have expertise in the implementation of the CounterACT research
program.

NIH Project Scientists will have substantial
scientific-programmatic involvement during conduct of this activity, through
technical assistance, advice, and coordination above and beyond normal program
stewardship for grants.

NIH Project Scientists will be responsible for assessing the
progress of the projects toward the accomplishment of specified milestones, and
for recommending if further funds should be released to the project.

NIH Project Scientists will facilitate the establishment of
contacts and collaborations between awardees of the CounterACT research program
and other persons or organizations whose participation will assist with the
accomplishment of project goals. These persons or organizations may include the
FDA, disease voluntary organizations, pharmaceutical companies, or research
organizations that can provide essential services on contract.

An important part of the CounterACT research program is the
coordination of research efforts across different funding mechanisms and
research structures, and coordination among efforts aimed at different
countermeasures. NIH Project Scientists will have the primary responsibility
for this overall coordination.

Additionally, an agency Program Official will be responsible
for the normal scientific and programmatic stewardship of the award and will be
named in the award notice. The assigned Program Official may also serve as an
NIH Project Scientist.

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and
NIH staff as described above.

Dispute Resolution:

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel
composed of three members will be convened. It will have three members: a
designee of the Steering Committee chosen without NIH staff voting, one NIH
designee, and a third designee with expertise in the relevant area who is
chosen by the other two; in the case of individual disagreement, the first
member may be chosen by the individual awardee. This special dispute resolution
procedure does not alter the awardee's right to appeal an adverse action that
is otherwise appealable in accordance with PHS regulation 42 CFR Part 50,
Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required
to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR)
and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.